← Back to Search

Checkpoint Inhibitor

Regorafenib + Immunotherapy for Colorectal Cancer

Phase 1
Waitlist Available
Led By Marwan G Fakih
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Microsatellite status should be performed per local standard of practice (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], or next-generation sequencing). Only participants with pMMR/MSS metastatic colorectal cancer (mCRC) are eligible
Histological or cytological confirmed advanced, metastatic, or progressive mismatch repair protein proficient (pMMR)/microsatellite stable (MSS) adenocarcinoma of colon or rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study Summary

This trial is studying regorafenib in combination with ipilimumab and nivolumab to see if it can help to treat patients with colorectal cancer that has spread and is resistant to chemotherapy.

Who is the study for?
This trial is for adults with metastatic colorectal cancer that's stable at the microsatellite level and hasn't responded to chemotherapy. Participants should have a good performance status, acceptable organ function tests, measurable disease, and no prior treatment with the study drugs. They must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of Regorafenib (a growth inhibitor), Ipilimumab, and Nivolumab (both immune system boosters) in patients whose colorectal cancer has spread and resisted chemotherapy. It aims to find the safest dose while observing how well these drugs work together against cancer.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, diarrhea, skin reactions, liver enzyme changes, immune-related conditions like inflammation in organs or glands (thyroiditis), potential infections due to lowered immunity, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My colorectal cancer is not microsatellite unstable.
Select...
My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer's RAS and BRAF gene status is known.
Select...
I can swallow and absorb pills.
Select...
I can provide a recent sample of my tumor for the study.
Select...
I agree to use birth control during the study and for some months after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended dose level of the combination
Secondary outcome measures
Duration of response
Objective response rate (ORR)
Overall survival
+1 more
Other outcome measures
Immune response

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
90%
Diarrhoea
78%
Nausea
61%
Vomiting
61%
Fatigue
54%
Abdominal pain
37%
Neutropenia
32%
Neuropathy peripheral
27%
Constipation
24%
Dehydration
24%
Weight decreased
22%
Peripheral sensory neuropathy
22%
Anaemia
20%
Cough
20%
Hypokalaemia
20%
Thrombocytopenia
17%
Back pain
17%
Urine ketone body present
17%
Chills
17%
Proteinuria
17%
Epistaxis
15%
Dyspnoea
15%
Headache
15%
Urine leukocyte esterase positive
15%
Dyspepsia
15%
Mucosal inflammation
15%
Pyrexia
15%
Hypertension
12%
Stomatitis
12%
Leukopenia
12%
Blood alkaline phosphatase increased
12%
Gastrooesophageal reflux disease
12%
Lymphopenia
12%
Dysgeusia
12%
Dizziness
12%
Insomnia
12%
Anxiety
10%
Neutrophil count decreased
10%
Blood bilirubin increased
10%
Temperature intolerance
10%
Pain in extremity
10%
Alopecia
10%
Pulmonary embolism
7%
Dry mouth
7%
Ascites
7%
Arthralgia
7%
Myalgia
7%
Platelet count decreased
7%
Small intestinal obstruction
7%
White blood cell count decreased
7%
Abdominal pain upper
7%
Asthenia
7%
Muscle spasms
7%
Chromaturia
7%
Urinary tract infection
7%
Depression
5%
Hyponatraemia
5%
Abdominal distension
5%
Flatulence
5%
Oedema peripheral
5%
Rash
2%
Enteritis
2%
Colitis
2%
Non-cardiac chest pain
2%
Respiratory failure
2%
Clostridium difficile colitis
2%
deep vein thrombosis
2%
Dysphagia
2%
Palmar-plantar erythrodysaesthesia syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (regorafenib, nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive regorafenib PO QD on days 1-21, nivolumab IV over 30 minutes Q2W, and ipilimumab IV over 30 minutes Q6W. Cycles repeat every 28 day for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2640
Nivolumab
2014
Completed Phase 3
~4750
Regorafenib
2014
Completed Phase 2
~1580

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,412 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,125 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04362839 — Phase 1
Rectal Cancer Research Study Groups: Treatment (regorafenib, nivolumab, ipilimumab)
Rectal Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04362839 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04362839 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the indications for Regorafenib?

"Regorafenib is a common treatment for unresectable melanoma, as well as squamous cell carcinoma and other high-risk forms of cancer with the potential for recurrence."

Answered by AI

Are there any limitations on the number of participants recruited for this clinical trial?

"Unfortunately, this trial is not accepting new candidates as of now. Initially posted on May 27th 2020 and last updated August 22nd 2022, other options are available with 1989 studies actively recruiting colorectal cancer patients while 809 trials require Regorafenib participants."

Answered by AI

Are there any previous experiments that have evaluated the effectiveness of Regorafenib?

"Currently, 809 medical trials are studying the efficacy and safety of Regorafenib with 91 studies in Phase 3. Although most of these experiments take place in Pittsburgh, Pennsylvania; 43504 other locations around the world have joined this research project."

Answered by AI

Is there an ongoing recruitment period for this research study?

"This medical experiment is no longer enrolling patients, with the initial posting on May 27th 2020 and last update occurring on August 22nd 2022. Fortunately there are numerous other studies that still need people to participate; 1989 trials are seeking individuals suffering from colorectal cancer while 809 experiments require participants for Regorafenib treatments."

Answered by AI

Has Regorafenib received official sanction from the Food and Drug Administration?

"Regorafenib's safety score is a 1 since this is still at the Phase I stage in terms of clinical trials. This indicates that there is limited data to support its efficacy and safety profile."

Answered by AI
~2 spots leftby Jun 2024